Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania

Anne Ammerdorffer; Sara Rushwan; Rebecca Timms; Philip Wright; Leanne Beeson; Adam J Devall; Kristie-Marie Mammoliti; Fadhlun M Alwy Al-Beity; Hadiza Galadanci; G Justus Hofmeyr; Mandisa Singata-Madliki; Zahida Qureshi; Pete Lambert; Ioannis D Gallos; Arri Coomarasamy; A Metin Gülmezoglu

doi:10.1002/ijgo.14197

Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania

Anne Ammerdorffer^*, Sara Rushwan, Rebecca Timms, Philip Wright, Leanne Beeson, Adam J Devall, Kristie-Marie Mammoliti, Fadhlun M Alwy Al-Beity, Hadiza Galadanci, G Justus Hofmeyr, Mandisa Singata-Madliki, Zahida Qureshi, Pete Lambert, Ioannis D Gallos, Arri Coomarasamy, A Metin Gülmezoglu

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

OBJECTIVE: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.

METHODS: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.

RESULTS: Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.

CONCLUSION: While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.

Original language	English
Pages (from-to)	46-55
Number of pages	10
Journal	International Journal of Gynecology & Obstetrics
Volume	158
Issue number	S1
DOIs	https://doi.org/10.1002/ijgo.14197
Publication status	Published - 28 Jun 2022

Bibliographical note

Keywords

Female
Humans
Kenya
Nigeria
Oxytocin/therapeutic use
Postpartum Hemorrhage/drug therapy
Pregnancy
South Africa
Tanzania
Tranexamic Acid/therapeutic use

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Ammerdorffer, A., Rushwan, S., Timms, R., Wright, P., Beeson, L., Devall, A. J., Mammoliti, K.-M., Alwy Al-Beity, F. M., Galadanci, H., Hofmeyr, G. J., Singata-Madliki, M., Qureshi, Z., Lambert, P., Gallos, I. D., Coomarasamy, A., & Gülmezoglu, A. M. (2022). Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania. International Journal of Gynecology & Obstetrics, 158(S1), 46-55. https://doi.org/10.1002/ijgo.14197

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title = "Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania",

abstract = "OBJECTIVE: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.METHODS: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.RESULTS: Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.CONCLUSION: While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.",

keywords = "Female, Humans, Kenya, Nigeria, Oxytocin/therapeutic use, Postpartum Hemorrhage/drug therapy, Pregnancy, South Africa, Tanzania, Tranexamic Acid/therapeutic use",

author = "Anne Ammerdorffer and Sara Rushwan and Rebecca Timms and Philip Wright and Leanne Beeson and Devall, {Adam J} and Kristie-Marie Mammoliti and {Alwy Al-Beity}, {Fadhlun M} and Hadiza Galadanci and Hofmeyr, {G Justus} and Mandisa Singata-Madliki and Zahida Qureshi and Pete Lambert and Gallos, {Ioannis D} and Arri Coomarasamy and G{\"u}lmezoglu, {A Metin}",

note = "{\textcopyright} 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.",

year = "2022",

month = jun,

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doi = "10.1002/ijgo.14197",

language = "English",

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Ammerdorffer, A, Rushwan, S, Timms, R, Wright, P, Beeson, L, Devall, AJ, Mammoliti, K-M, Alwy Al-Beity, FM, Galadanci, H, Hofmeyr, GJ, Singata-Madliki, M, Qureshi, Z, Lambert, P, Gallos, ID , Coomarasamy, A & Gülmezoglu, AM 2022, 'Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania', International Journal of Gynecology & Obstetrics, vol. 158, no. S1, pp. 46-55. https://doi.org/10.1002/ijgo.14197

TY - JOUR

T1 - Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania

AU - Ammerdorffer, Anne

AU - Rushwan, Sara

AU - Timms, Rebecca

AU - Wright, Philip

AU - Beeson, Leanne

AU - Devall, Adam J

AU - Mammoliti, Kristie-Marie

AU - Alwy Al-Beity, Fadhlun M

AU - Galadanci, Hadiza

AU - Hofmeyr, G Justus

AU - Singata-Madliki, Mandisa

AU - Qureshi, Zahida

AU - Lambert, Pete

AU - Gallos, Ioannis D

AU - Coomarasamy, Arri

AU - Gülmezoglu, A Metin

PY - 2022/6/28

Y1 - 2022/6/28

N2 - OBJECTIVE: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.METHODS: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.RESULTS: Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.CONCLUSION: While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.

AB - OBJECTIVE: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.METHODS: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.RESULTS: Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.CONCLUSION: While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.

KW - Female

KW - Humans

KW - Kenya

KW - Nigeria

KW - Oxytocin/therapeutic use

KW - Postpartum Hemorrhage/drug therapy

KW - Pregnancy

KW - South Africa

KW - Tanzania

KW - Tranexamic Acid/therapeutic use

U2 - 10.1002/ijgo.14197

DO - 10.1002/ijgo.14197

M3 - Article

C2 - 35762808

SN - 0020-7292

VL - 158

SP - 46

EP - 55

JO - International Journal of Gynecology & Obstetrics

JF - International Journal of Gynecology & Obstetrics

IS - S1

ER -

Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania

Abstract

Bibliographical note

Keywords

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